Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Recruiting
Phase 3
Interventional Study
Glioblastoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 766 (estimated)
- Sponsor
- GT Medical Technologies, Inc. · Industry
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About This Trial
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:
* A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.
* A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).
* A…
Trial Locations
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Eligibility Criteria
Major Criteria Includes the Following:
Inclusion Criteria
* Patients must be ≥18 years of age.
* Have radiographic suspicion of newly diagnosed glioblastoma (GBM).
o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL…
Contacts